510(k) K221569
K221569 is an FDA 510(k) premarket notification submitted by Shenzhen Fansizhe Science and Technology Co., Ltd. for the device "Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K". The FDA issued a decision of Substantially Equivalent on June 30, 2022. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Shenzhen Fansizhe Science and Technology Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2022
- Date Received
- May 31, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over-The-Counter Hair Removal
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.